In 2008, an estimated 1.4 million new patients will be diagnosed with cancer and most will not be eligible for surgery or will fail traditional regimens such as chemotherapy and radiation. As an alternative, thermal tumor ablation aims to destroy tumors using energy delivered by percutaneous devices placed under imaging guidance. Microwave energy has many advantages for tumor ablation, including faster heating, more consistent results and improves multiple-applicator capabilities. However, clinically available microwave ablation devices may be too large for safe percutaneous use, create zones of ablation too small to adequately treat most tumors, allow only one antenna to be powered by each generator, and require awkward setups for power distribution and coolant flow. These limitations have prevented microwaves from becoming the dominant ablation modality, despite substantial advantages over the clinical standard, radio frequency (RF) ablation. NeuWave Medical, Inc. (formerly Micrablate, LLC) is a spin-off company from the University of Wisconsin with a mission to commercialize a new microwave system - the TheraWave 100 - for image-guided tumor ablation that markedly improves physicians' ability to treat even the most challenging tumors. Key features of the NeuWave system under development include the industry's smallest-diameter needle and largest zones of ablation, a state-of-the-art integrated cooling system that prevents dangerous heating throughout the entire system, a novel power distribution design that improves system efficiency, increases power delivered to the tissue and reduces setup/takedown complexity, and a user-friendly design that will help improve adoption. We have reached the milestones set by our Phase I SBIR aims. In particular, we proved the feasibility of a prototype system having a cooled-antenna design that enabled a significant increase in power delivery while eliminating dangerous shaft heating, yet maintained a slim 17-gauge profile. The prototype antenna was shown to create ablations 50 percent larger in volume with less variability than a clinical RF ablation system in normal lung. As a next step, the Phase II project will extend and validate our antenna development with modifications in system-level design that will create a more physician-friendly microwave ablation system. Upon reaching our Phase II aims, NeuWave will have several key advantages over existing commercial systems including: new techniques for antenna and cable cooling optimized power distribution to create a multiple-antenna system using a single generator, increased system efficiency, and user-friendly control interfaces. Our market analysis and feedback from potential customers indicates that these technological features will give NeuWave's system a significant competitive advantage over current commercially available systems. The company has set forth an excellent commercialization strategy and clearly has expertise in the area of commercialization of medical products. During the course of this project, NeuWave plans to file an FDA 510(k) application for soft-tissue use. The completed microwave ablation system will be tentatively scheduled for market launch in Spring 2011 and possibly marketed to companies at the forefront of medical device and ablation technology, such as Johnson and Johnson or Boston Scientific. PUBLIC HEALTH RELEVANCE: NeuWave Medical's microwave ablation technologies developed in this proposal will combine the best of engineering and medicine into a tool that clinicians will use to treat cancer with minimal invasiveness, low morbidity and rapid recovery. Commercialization of this system will have a substantial impact on the treatment of cancers of the lung, liver, kidney and bone for maximum cancer patient benefit. [unreadable] [unreadable] [unreadable]